Clinical Evaluation of the Lepu Medical PPH Stapler versus the Golden Stapler (XNY) in Hemorrhoidal Disease and Rectal Mucosal Prolapse: A Regulatory Validation Study

Document Type : Research/Original Article

Authors

Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

10.30476/acrr.2026.110676.1284

Abstract

Background: Stapled hemorrhoidopexy (PPH) is a well-established surgical procedure for treating high-grade
hemorrhoidal disease and rectal mucosal prolapse. Regulatory clinical validation is essential to ensure the
device’s safety and performance equivalence.
Methods: In this prospective regulatory evaluation, 23 patients underwent PPH using either the Lepu Medical
stapler (n=10) or the XNY (Golden Stapler) device (n=13). Intraoperative technical success, surgeon-reported
device fluency (5-point scale), hemostasis, postoperative pain (VAS), and early complications during a 3-month
follow-up period were assessed.
Results: Technical success was achieved in all cases, with complete circumferential staple lines. The XNY
stapler demonstrated higher mean fluency scores than the Lepu Medical stapler (4.8 vs. 4.1). Minor staple-line
overstitching occurred in 20% and 23% of cases, respectively. Postoperative pain was low, and no anal stenosis,
infection, or recurrence was observed after three months.
Conclusion: Both staplers provided safe and effective treatment. The XNY stapler demonstrated a statistically
significant advantage in fluency scores compared to the Lepu Medical stapler. However, the Lepu Medical
stapler met all clinical safety requirements, including pain, recovery, and complication rates, suggesting that
its use in routine surgical practice and national healthcare procurement could be as safe as the XNY device.

Keywords

References

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